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Stress Disorders, Post-TraumaticPhase 2NCT00262223

Combined Treatment for Alcohol-Dependent Individuals With PTSD

A Phase 2 study testing Seeking Safety and Sertraline in people with Stress Disorders, Post-Traumatic and Alcohol Abuse, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Seeking Safety and Sertraline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
69 participants
Where
1 siteUnited States
Study dates
May 2006to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females who are a minimum of 18 years and maximum of 65 years.
  • Participants meet Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) criteria for current alcohol misuse, abuse or dependence.
  • Participants must have current alcohol use over past 90 days defined by more than or equal to 2 heavy drinking days or more than or equal to 14 drinks over 30 consecutive days or abstinence less than or equal to 21 consecutive days.
  • Participants meet criteria for full or subthreshold PTSD. Subthreshold PTSD criteria differs from full PTSD in that the individual meets cluster C (numbing) OR cluster D (hyperarousal) whereas full PTSD requires that the individual meets both cluster C and D.
  • Participants demonstrate no gross organic mental syndrome.
  • Participants are capable of giving informed consent and capable of complying with study procedures.
  • Participants speak English.

Who cannot join

  • Individuals who are at significant risk for suicide based on their current mental state or history.
  • Participants with other current Axis I psychiatric disorders that, in the investigators' judgment, are unstable and would be disrupted by study medications. Current diagnosis of Bipolar I and psychotic disorders are exclusionary.
  • Participants who are currently severely depressed.
  • Participants with a history of psychosis or mania.
  • Participants with organic mental syndrome.
  • Participants physiologically dependent on any substance other than alcohol (excluding nicotine or caffeine or medically stable and managed methadone).
Show all 14Show fewer
  • Participants with comorbid substance abuse disorder who require detoxification treatment.
  • Participants with unstable or significant physical disorders (e.g., uncontrolled hypertension, poorly-controlled diabetes, alanine aminotransferase/aspartate aminotransaminase (AST/ALT) three times the upper limit of normal) that would increase the risk of study participation.
  • Participants with a known history of seizures (not related to alcohol withdrawal).
  • Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention.
  • Participants currently taking prescribed psychotropic medication that is contraindicated for use with sertraline (e.g. antidepressant medications except for mirtazapine or trazodone when used for the treatment of insomnia ) and/or psychotropic medications where the participant has not achieved a stabilized regimen. Participants that are stable on medications that are not contraindicated with the use of sertraline (e.g., Methadone or Adderall) will not be excluded.
  • A history of an allergic reaction to sertraline.
  • Women who are currently pregnant or are trying to get pregnant or are nursing or are pre-menopausal and sexually active but not using effective birth control.
  • Participants refusing to be audio or videotaped.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City College, City University of New York

    New York, New York, 10031

Other trials in United States

About this study

This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive behavioral treatment intervention called "Seeking Safety" + Medication ("Zoloft") or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment.

Read the detailed description

The impetus for the current study is to contribute to the development of effective treatments targeted for men and women with either alcohol misuse (e.g., hazardous or binge drinking) or alcohol use disorders (e.g. alcohol abuse or alcohol dependence) and comorbid PTSD. Research findings have shown that these individuals have poorer treatment outcomes and show more severe symptoms than treatment seeking alcohol-misusing or alcohol dependent participants without PTSD. The aim of this study is to replicate and expand on 1) pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for individuals with comorbid substance use disorders and PTSD, "Seeking Safety" 2) preliminary results on the effectiveness of the antidepressant sertraline ("Zoloft") for a dually diagnosed population and 3) the examination of the effectiveness of these interventions over either treatment alone. We are comparing "Seeking Safety" alone to "Seeking Safety" in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use and PTSD symptoms. Participants will be randomly assigned to one of two treatments (Seeking Safety + Med or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment. Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes; impact of combined treatment on treatment participation and global psychiatric symptoms; differences in the time course and order of changes in alcohol and drug use and PTSD symptoms by condition.

Being tested
Seeking Safety, Sertraline, Pill placebo
Keywords
Co-morbid alcohol dependence and PTSD, Alcohol and other drug use disorders, Treatment outcome
Medical subject headings
Stress Disorders, Post-Traumatic, Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seeking SafetyBehavioural

    Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders

  • SertralineDrug

    Also called Zoloft

    An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type

  • Pill placeboDrug

Study groups in NCT00262223
Study groupRoleWhat they receive
1) Seeking Safety + SertralineActive comparatorSeeking Safety + Sertraline
Receives: Behavioral: Seeking Safety; Drug: Sertraline
2) Seeking Safety + PlaceboPlacebo comparatorSeeking Safety + Placebo;
Receives: Behavioral: Seeking Safety; Drug: Pill placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heavy Drinking Days/Week

    Measured: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up

  2. PTSD Symptom Severity / Clinician Administered PTSD Scale

    Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).

    Measured: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262223
Sponsor's protocol ID
#6266R-NIAAAHIE014341
Other IDs
R01AA014341-06
Status last verified
Feb 2020
First submitted
5 Dec 2005
Last updated
3 Mar 2020
Data monitoring committee
Yes

Publications

  • Hien DA, Levin FR, Ruglass LM, Lopez-Castro T, Papini S, Hu MC, Cohen LR, Herron A. Combining seeking safety with sertraline for PTSD and alcohol use disorders: A randomized controlled trial. J Consult Clin Psychol. 2015 Apr;83(2):359-69. doi: 10.1037/a0038719. Epub 2015 Jan 26.

    PubMed 25622199

  • Ruglass LM, Pedersen A, Cheref S, Hu MC, Hien DA. Racial differences in adherence and response to combined treatment for full and subthreshold post-traumatic stress disorder and alcohol use disorders: A secondary analysis. J Ethn Subst Abuse. 2016 Oct-Dec;15(4):434-448. doi: 10.1080/15332640.2015.1056927. Epub 2015 Sep 30.

    PubMed 26422415

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Seeking Safety and Sertraline in people with Stress Disorders, Post-Traumatic and Alcohol Abuse, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heavy Drinking Days/Week (time frame: Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262223, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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